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Yervoy/Zelboraf Combo Trial Fails, But Sequential Study Continues

 
• By Emily Hayes

Small Phase I melanoma study testing a combination of Zelboraf and Yervoy was closed early due to an unexpectedly high rate of liver toxicity, investigators report in letter to the editor of the New England Journal of Medicine. A sequential study of Yervoy and Zelboraf and other combination studies proceed as planned.

An eagerly awaited Phase I/II study of Roche’s Zelboraf and Bristol-Myers Squibb Co.’s Yervoy has been terminated due to liver toxicity, but the drugs still could find a role for use in immediate sequence.

Both Bristol’s CTLA inhibitor Yervoy (ipilimumab) and Roche’s BRAF inhibitor Zelboraf (vemurafenib) revolutionized the melanoma field when they cleared FDA...

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More from Clinical Trials

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

More from R&D

Nipah Vaccine With ‘Pandemic Potential’ Wins EMA PRIME Designation

 
• By Neena Brizmohun

The developers of the ChAdOx1 NipahB vaccine will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.